PRECISION7 FOR ASTIGMATISM
Received Jun 24, 2026
Report 9610813-2026-00029 · MDR key 25607722
Device
Generic name
Lenses, Soft Contact, Extended Wear
Manufacturer
Ciba Vision GmbhModel number
NACatalog number
000000000900469476
Lot number
ASKU
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Corneal Ulcer
Narrative
Description of Event or Problem
AS INITIALLY REPORTED BY A HEALTHCARE PROFESSIONAL ON BEHALF OF THE CONSUMER, STATED THAT THEY EXPERIENCED A CORNEAL ULCER IN THE LEFT EYE AFTER INSERTING THE CONTACT LENS. THE CONSUMER DISCONTINUED USE OF THE CONTACT LENSES FOLLOWING THE EVENT. THE PHYSICIAN REPORTED THAT A CHANGE IN PRESCRIPTION WAS REQUIRED DUE TO THE EVENT, WHICH WAS ATTRIBUTED TO THE CONTACT LENS, AND A NEW PRESCRIPTION WAS SUBSEQUENTLY REORDERED FOR THE CONSUMER. THE CURRENT STATUS OF CONSUMER¿S EYE WAS SYMPTOMS RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Additional Manufacturer Narrative
H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION; THE LOT NUMBER IS UNKNOWN. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).